Prevention of Perioperative Pulmonary Complications by Lung Recruitment During Laparoscopic Surgery in Trendelenburg Head-down Position
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Incidence of hypoxia
研究概览
简要总结
Perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. The possibility of reducing perioperative pulmonary complications by lung recruitment, which uses positive pressure to prevent alveolar collapse, has been reported. Although laparoscopic surgery, which has been widely performed in recent years, can reduce the invasiveness of the operation, it is prone to alveolar collapse due to increased abdominal pressure and diaphragm elevation. The purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in Trendelenburg head-down position prevents hypoxemia due to lung collapse.
详细描述
The multi-center RCT will enroll 80 patients who have laparoscopic surgery in Trendelenburg head-down position. Informed consent will be obtained for study subjects who meet the selection criteria, and the subjects will be enrolled in Electronic Data Capture and randomized into two groups. Patients will be admitted to the operating room for induction of anesthesia and tracheal intubation. In the control group, mechanical ventilation will be performed according to the initial settings and protocols. In the intervention group, after intubation, the ventilator will be initially set up, and the first pulmonary recruitment will be performed immediately after the start of the laparoscopy, followed by recruitment every 30 minutes until the end of the laparoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours
排除标准
- •Lateral or supine position
- •BMI > 35
- •One-second rate <70%, %VC <80%, obstructive, restrictive, with bra
- •Cardiovascular disease (NYHA III or higher)
- •Intracranial hypertensive disease
- •Emergency surgery
- •Pregnancy
- •Patients judged unsuitable by the anesthesiologist in charge
结局指标
主要结局
Incidence of hypoxia
时间窗: During laparoscopy procedure
SpO2 less than 95% or more than 2% decrease from baseline
Time to onset of hypoxia
时间窗: During laparoscopy procedure
Duration from the start of laparoscopic surgery to the onset of hypoxia
次要结局
- Rate of decrease in SpO2(During laparoscopy procedure)
- Safety endpoint: total fluid infusion(During surgery)
- Postoperative hypoxia(the day after surgery)
- Ventilator setting at the end of surgery(During surgery)
- Safety endpoint: Circulatory agonist use(During surgery)
- Safety endpoint: incidence of complications(During surgery)
- compliance rate of lung recruitment(During laparoscopy procedure)